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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS PROTURA SOFTWARE

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MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS PROTURA SOFTWARE Back to Search Results
Model Number MT6XSM1.7.1
Device Problems Computer Software Problem (1112); Application Program Problem (2880); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2016
Event Type  malfunction  
Manufacturer Narrative
Upon investigation it was determined the positioning discrepancy results from the execution of positioning shifts via the "split shift" functionality of the protura software. The split shift function allows for translation shifts to be exported and executed by the linac pedestal and then the protura compensates on the rotational aspects of the move. When the split shift functionality is utilized,the protura system is locking into the pivot point associated with the initial location prior to executing the rotations and sending the translational requirements to the pedestal. The protura is then executing rotational shifts with respect to the original pivot point location rather than the pivot point that would have resulted from the translation after the shifts made by the pedestal. As a result, the larger the translation (>3 cm) the larger the offset to isocenter. The split shift feature which allows for >3 cm shifts is only available on protura software versions 1. 6. 1, 1. 7. 0, and 1. 7. 1 and set with a varian interface. Civco will provide a safety notification to all users of these versions of this issue and detail how to set up the software to utilize the alternative software functionality "all 6 degrees protura". Using all 6 degrees protura setting, the problem identified with the software does not exist. Software version available on site.
 
Event Description
User facility developed a quality assurance test for the use of the protura system and verify it is within 1 mm of treatment isocenter. Prior to use, the site identified that while performing the testing on a phantom it was 2. 5 mm off in the lateral direction and 1. 5 mm off in the vertical direction when translational offsets between 3-5 cm in all three directions are employed.
 
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Brand NamePROTURA SOFTWARE
Type of DevicePROTURA SOFTWARE
Manufacturer (Section D)
MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
1401 8th st se
orange city IA 51041
Manufacturer Contact
james leong
1401 8th st se
orange city, IA 51041
3192486502
MDR Report Key6586240
MDR Text Key76024810
Report Number1932738-2016-00001
Device Sequence Number1
Product Code JAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial
Report Date 03/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT6XSM1.7.1
Device Catalogue NumberMT6XSM1.7.1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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